European regulators Struggle with Globalisation of Clinical Trials

Traditionally, clinical trials were predominantly conducted in North America, Western Europe and Japan, but over the past decade there has been a dramatic shift towards using other regions. The extent of this international trend was illustrated in a global analysis of the period between 2002 and 2006, which examined the regional share of total sites and the growth rates for different regions (1). According to this analysis, the share of global sites accounted for by Western Europe increased by a modest 3%, whereas for Eastern Europe the share rose by 24%. Meanwhile, both Asia and Latin America's shares increased by around 20%. The trends come as little surprise, since it is now almost standard practice to incorporate so-called emerging market regions and rapidly developing countries in clinical development programmes (2).

Faster patient recruitment and lower trial operational costs are factors that have attracted companies to newer regions. In addition, many of these areas represent pharmaceutical markets in their own right and products may be looked upon more favourably if they have been tested in local populations. Many governments in emerging markets have recognised this interest from global companies and have taken measures to attract investment by decreasing bureaucracy and improving their regulatory systems. In China, for example, centralising the regulatory agency helped to decrease the number of conflicting standards between the central and local governments, and has led to improvements in approval times (3).

Growing criticism

While the pharmaceutical industry has expanded its clinical trials internationally, this shift has been viewed with concern in some quarters. Some observers believe that there has been too much emphasis on economic benefits and that the ethical angles of globalisation have not been fully explored (2). In particular, there have been several media reports criticising the use of developing world regions for clinical trials. In a television programme called "Dying for Drugs," which aired in the UK, Pfizer was heavily criticised for the manner in which it conducted a trial in Nigeria (4–7).

The anti-industry slant of the programme prompted a furious response from the Association of the British Pharmaceutical Industry (ABPI) and Pfizer said that the coverage of the company's activities was "misleading" (8). Nevertheless, unfavourable media coverage continues to emerge. In 2011, the UK's Independent newspaper ran a series of articles highlighting a series of clinical trial violations in India (9-11). The newspaper highlighted how drug trials were carried out on survivors of the 1984 Bhopal gas disaster without their knowledge and how certain Indian hospitals were generating considerable revenue from UK, US and French pharmaceutical companies for clinical trials (10). The resulting outcry led to pressure on India's regulatory agency to tighten regulations and protect subjects from exploitation. However, the media coverage then expanded to highlight examples in different countries, including those in Europe (10).

The Dutch nongovernmental organisation, Wemos, which advocates for the right to health of people in developing countries, together with international partner organisations and journalists, began to document cases of unethical trials and lobby European politicians and policymakers to address the highlighted problems (12). Wemos' campaign has involved collecting and publishing testimonies from trial subjects, their relatives and others investigating the issue, but the organisation has not singled out individual companies (12).

These campaigns have had an effect, with groups of influential European MEPs raising the issue in the European parliament and calling for an appropriate response from the European regulators (9–11). Dr Peter Liese, a German Christian Democratic MEP was of the opinion that the European ban of an unethically tested drug would serve as an appropriate deterrent to wrongdoers in the pharmaceutical industry (10). He believed that appropriate laws to prevent breaches in conduct existed, but were not being implemented. Meanwhile, Margrete Auken, a Danish Green Party MEP, was quoted in the media as equating unethical clinical trials with organ trafficking and called for companies to be "named and shamed" (10).